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This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.
Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:
Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMICUS Therapeutic plasma exchange, TPE | Experimental | Patients are randomized to either TPE on AMICUS or Spectra. |
|
| Spectra Therapeutic plasma exchange, TPE | Active Comparator | Patients are randomized to either TPE on AMICUS or Spectra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic plasma exchange | Device | Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure. Plasma Efficiency = (plasma removed/plasma processed)*100 | After completion of the TPE procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measured by Adverse Events During the TPE Procedure | Adverse events were collected during each TPE procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peyton Metzel, PhD | Fenwal, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States | ||
| Mayo Clinic |
Patients were required to complete two (2) procedures. First procedure was randomized to either Therapeutic plasma exchange on active comparator (AMICUS) or current device (Spectra). The second procedure was completed within approximately 5 weeks on the other device per physician prescription.
The study opened enrollment on Sept 2010 at three hospitals-Yale New Haven Hospital, Mayo Clinic and University of Virginia Health System. A 4th site, BloodCenter of Wisconsin opened enrollment April,2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spectra First, Then AMICUS | Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS). |
| FG001 | AMICUS First, Then Spectra | Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First TPE Procedure |
| |||||||||||||
| Second TPE Procedure |
|
Demographics were reported for the evaluable patient population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Includes groups randomized to receive Spectra first and AMICUS first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure. Plasma Efficiency = (plasma removed/plasma processed)*100 | A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures. | Posted | Mean | Full Range | percentage of plasma removal efficiency | After completion of the TPE procedure. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study Population | Includes groups randomized to receive Spectra first and AMICUS first. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizzy/Light-Headed | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Mgr. Clinical Affairs | Fenwal, Inc | 847-550-5620 | carrie.pineda@fenwalinc.com |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007674 | Kidney Diseases |
| D006402 | Hematologic Diseases |
| D010265 | Paraproteinemias |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| BloodCenter of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Spectra (Control) | Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator. |
|
|
|
| Secondary | Safety Measured by Adverse Events During the TPE Procedure | Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported. | Posted | Number | participants | Adverse events were collected during each TPE procedure. |
|
|
|
| 0 |
| 37 |
| 7 |
| 37 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Infiltration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Chills | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Rigors | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
Publication of data and/or information derived from the study requires prior review and approval by Sponsor.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001796 | Blood Protein Disorders |
| D007160 | Immunoproliferative Disorders |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |